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Tissue engineering of the right heart outflow tract by a biofunctionalized bioresorbable polymeric valved tube (TEH-TUBE)
Start date: Jan 1, 2014, End date: Dec 31, 2017 PROJECT  FINISHED 

Approximately 42% of infants’ mortality in the world is related to congenital heart defects (prevalence: 8-12/1000 births). Over 1/3 require the reconstruction of the right ventricular outflow tract (RVOT) by surgical procedures which currently use inert materials without any growth potential. Consequently, multiple reoperations are often required, with their attendant high risk of mortality and morbidity.The TEH-TUBE project will address these limitations by creating a novel bioabsorbable biomaterial using a polymeric valved tube either seeded with autologous adipose tissue derived stem cells (ADSC) or functionalized by a peptidic sequence triggering homing of the host cells onto the scaffold to make it a living self-populated structure. During the project we will:• Compare a number of polymers, including but not limited to polydioxanone, polyhydroxyalkanoate, and poly-ester-urethane-ureas, processed by electrospinning to generate a competent valved tube• Compare, in the selected polymer, different methods of functionalisation using in vitro mechanical and biological tests as well as in vivo animal experiments (primarily rats)• Validate the ultimate combination (polymer + functionalisation technique) in a clinically relevant large animal model (in this case, the growing lamb to specifically assess the regenerative and growth potential of the composite construct)This stepwise approach will be conducted within a tightly controlled regulatory framework to ensure that the final product meets the current ATMP requirements for phase I/II clinical studies and, if successful, ultimate commercialization.Our TEH-TUBE project aims at developing an innovative biomaterial for the treatment of congenital heart abnormalities in children and young adults. By creating a material whose growth will keep pace with that of the patient, this product, geared to become an ATMP, should decrease the risk of reoperative surgeries, improve the quality of life and ultimately have a positive impact on healthcare costs.
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